Mucosis starts clin­i­cal study with its lead prod­uct, FLUGEM™

Dutch biotech­nol­o­gy com­pa­ny Mucosis B.V. today announced the start of a Phase 1 clin­i­cal study with its lead prod­uct FluGEM™, a nov­el improved influen­za vac­cine for the elder­ly. It is the first-ever study in man with a vac­cine can­di­date based on Mimopath™, a pro­pri­etary plat­form tech­nol­o­gy for devel­op­ing more potent vac­cines.

The clin­i­cal study will be con­duct­ed in con­junc­tion with the Centre for Human Drug Research (CHDR; Leiden, the Netherlands). It is designed to test the safe­ty and tol­er­a­bil­i­ty of FluGEM™, as well as the mucos­al and sys­temic immune respons­es includ­ing cor­re­lates of pro­tec­tion against influen­za virus­es. The tri­al will involve FluGEM™ being admin­is­tered both as droplets in the nose and by intra­mus­cu­lar injec­tion.

Mucosis has eval­u­at­ed FluGEM™ for safe­ty and tox­i­c­i­ty in well-accept­ed ani­mal mod­els, and found it to be safe at all dos­es test­ed. Moreover, pre­clin­i­cal results show an induc­tion of robust mucos­al and sys­temic immu­ni­ty and supe­ri­or pro­tec­tion from an influen­za chal­lenge.

“We are very pleased with the on-sched­ule ini­ti­a­tion of this Phase 1 study,” said Govert Schouten, CEO of Mucosis. “This is an impor­tant step towards real­iz­ing our ambi­tion of tak­ing an improved flu vac­cine to the mar­ket. In addi­tion, this study will val­i­date Mimopath™ as a plat­form tech­nol­o­gy for the devel­op­ment of new vac­cines that pro­vide bet­ter and broad­er pro­tec­tion”.

The enroll­ment of vol­un­teers for the tri­al has been ini­ti­at­ed and immu­niza­tions are sched­uled to start in the next weeks. The vac­cine will be test­ed in 90 adult and 60 elder­ly tri­al­ists. Interim top-line data from the study are expect­ed to become avail­able before the end of 2011. The clin­i­cal study is finan­cial­ly sup­port­ed by Agentschap NL, an agency of the Dutch Ministry of Economic Affairs, Agriculture and Innovation.

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